STALEVO SIDE EFFECTS
The following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling:
- Falling Asleep During Activities of Daily Living and Somnolence
- Hypotension/Orthostatic Hypotension and Syncope
- Depression and suicidality
- Hallucinations/Psychotic-Like Behavior
- Impulse Control and/or Compulsive Behaviors
- Withdrawal-Emergent Hyperpyrexia and Confusion
- Diarrhea and Colitis
- Peptic Ulcer Disease
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment/total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in clinical practice.
The most commonly observed adverse reactions (incidence at least 3% greater than placebo incidence) in the double-blind, carbidopa-levodopa-placebo-controlled trials of entacapone (N=1,003 patients) associated with the use of carbidopalevodopa- entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, dry mouth, and urine discoloration.
The treatment difference incidence for premature study discontinuation for entacapone with levodopa and dopa decarboxylase inhibitor in the double-blind, placebo-controlled trials was 5%. The treatment difference incidence for the most frequent causes of study discontinuation was 2% for diarrhea, and 1% for other specific adverse reactions including psychiatric reasons, dyskinesia/ hyperkinesia, nausea, or abdominal pain.
Adverse Reaction Incidence In Controlled Clinical Studies Of Entacapone
Table 1 lists treatment emergent adverse reactions that occurred in at least 1% of patients treated with carbidopa/levodopa and 200 mg of entacapone who participated in the double-blind, placebo-controlled studies, and that were numerically more common in this group than in the carbidopa/levodopa plus placebo group. In these studies, either entacapone or placebo was added to carbidopa/levodopa (or benserazide/levodopa).
Table 1: Summary of Patients With Adverse Reactions After Start of Trial Drug Administration At Least 1% in Entacapone Group and Greater Than Placebo
|SYSTEM ORGAN CLASS Adverse Reaction||Carbidopa/levodopa plus Entacapone
(n=603) % of patients
|Carbidopa/levodopa plus Placebo
(n=400) % of patients
|SKIN AND APPENDAGES DISORDERS|
|MUSCULOSKELETAL SYSTEM DISORDERS|
|CENTRAL AND PERIPHERAL NERVOUS SYSTEM DISORDERS|
|SPECIAL SENSES, OTHER DISORDERS|
|GASTROINTESTINAL SYSTEM DISORDERS|
|Gastrointestinal Disorders NOS||1||0|
|RESPIRATORY SYSTEM DISORDERS|
|PLATELET, BLEEDING AND CLOTTINGDISORDERS|
|URINARY SYSTEM DISORDERS|
|BODY AS A WHOLE-GENERAL DISORDERS|
|RESISTANCE MECHANISM DISORDERS|
The following spontaneous reports of adverse events temporally associated with entacapone or Stalevo have been identified since market introduction and are not listed in Table 2. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish causal relationship to entacapone or Stalevo exposure.
Hepatitis with mainly cholestatic features has been reported.
Effects Of Gender And Age On Adverse Reactions
No differences were noted in the rate of adverse reactions attributable to entacapone alone by age or gender.
SRC: NLM .